Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.
Check against the official notice below — it lists the full affected range.
Stanbio Laboratory, LP is recalling Beta-Hydroxybutyrate LiquiColor, an in vitro diagnostic reagent used in laboratory testing. The recall affects 7,108 products distributed nationwide across the United States and internationally to Australia, Canada, Chile, Germany, Hong Kong, Singapore, Taiwan, Thailand, the United Kingdom, and Vietnam. The recall was initiated because the reagents deteriorated during storage, causing quality control values to fall below expected ranges or produce out-of-range results.
The affected products are identified by Catalog Number 2440-058 and Device Identifier 00657498000519, with the following lot numbers: 164312, 161081, 161039, 161031, and 158972. The source record does not specify what remedy or corrective action an affected consumer should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Reason for recall: Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Chile, Federal Republic of Germany, Hong Kong, Singapore, Taiwan, Thailand, United Kingdom, and Viet Nam. Quantity: 7,108 products Lot/code info: Catalog Number/Product Description: 2440-058/¿-Hydroxybutyrate LiquiColor Device Identifier: 00657498000519 Lot Numbers: 164312; 161081; 161039; 161031; 158972;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.